Dr. Michael Rosenberg will describe how fast access to metrics, flexible processes, and automated technology enable study monitors to increase efficiency
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Health Decisions CEO Explores Adaptive Monitoring Techniques for Late-Stage Clinical Studies in June 14 DIA Session
Dr. Michael Rosenberg will describe how fast access to metrics, flexible processes, and automated technology enable study monitors to increase efficiency
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Dr. Michael Rosenberg will describe how fast access to metrics, flexible processes, and automated technology enable study monitors to increase efficiency
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as TXT, PDF, TXT or read online from Scribd
Health Decisions CEO Explores Adaptive Monitoring Techniques for Late-Stage Clin
ical Studies in June 14 DIA Session
Dr. Michael Rosenberg will describe how fast access to metrics, flexible process es, and automated technology enable study monitors to increase efficiency Durham, NC, June 10, 2010 -- Health Decisions (www.HealthDec.com, Booth 929), a full-service clinical research organization (CRO) specializing in high-efficienc y adaptive solutions, announces that CEO Michael Rosenberg, MD, MPH will join a panel June 14 at the DIA Annual Meeting in Washington, DC. Centralized Monitorin g: When Does It Make Sense? will focus on the advantages and requirements of mon itoring programs that balance the needs of sponsor companies and investigative s ites in phase IIIb to postmarket clinical studies. According to Dr. Rosenberg, a centralized monitoring system should be based on t he same general principle as adaptive design, a hot topic in the industry. Adapt ive monitoring involves capturing and presenting site performance metrics to stu dy monitors in near-real time, allowing monitors to make mid-course adjustments to study operations based on current information. This enables decision-makers t o optimize site activity on a rolling and continuous basis for dramatic aggregat e time- and cost-savings. “Applied to site management, adaptive methodology empowers monitors to be more t han just box-checkers,” said Dr. Rosenberg. “Each team member has the training a nd tools to improve site performance. When the whole team is thinking critically about the overall health of the study, you get better quality data and faster e xecution at every stage, from start-up and enrollment through database lock and submission.” Centralized Monitoring: When Does It Make Sense? will explore monitoring solutio ns that provide economies of scale, allocate resources efficiently, optimize eve ry aspect of operations, and alleviate sponsors’ concerns about budget and timel ines. Such solutions include: Need-based monitoring visits: how to reliably and efficiently determine when to dispatch monitors to sites Managing based on performance metrics: which metrics to look for, how to track a nd report trends, and what actions to take when opportunities to improve efficie ncy are indicated Automated data capture and processing tools Electronic data as source documents The session will be chaired by Ramita Tandon, MPH, MSc, senior director, project management, per-approval services (PACE) at PAREXEL International. The session is part of the Clinical Research and Development/Clinical Supplies (CR/CS) track , and takes place June 14 from 3:30 – 5:00 p.m. EDT in Room 145B. For media information, please contact Katie Hendrick, Marketing Specialist at kh endrick@HealthDec.com; +1.919.967.1111 x116. For sales and marketing information, please contact Dean Bundschu, VP of Busines s Development at dbundschu@HealthDec.com; +1.919.967.1111 x510. About Health Decisions Health Decisions (www.HealthDec.com) is a global clinical research organization (CRO) committed to helping drug and device companies achieve greater success. Ou r sponsors rely on us to help them prove the value of their pipelines both faste r and with the smartest possible allocation of funds. Through Agile Clinical Dev elopment—a strategic combination of adaptive design and adaptive operations—Heal th Decisions optimizes every facet of clinical research from design protocol to the most detailed day-to-day management, so sponsors can make the most of compet itive market opportunities. Health Decisions is headquartered in Durham, NC, with over twenty years of exper ience helping sponsors achieve success in Phase I-IV trials across all major the rapy areas. For more information, please visit the company s website at www.Heal thDec.com. About the DIA Annual Meeting Hosted by the Drug Information Association, the DIA 46th Annual Meeting takes pl ace June 13 – 17, 2010 at the Walter E. Washington Convention Center, Washington , DC. The DIA Annual Meeting is the biopharmaceutical industry s largest, longes t running, best-value, global, multidisciplinary event. To learn more, visit DIA online. About the Drug Information Association (DIA) DIA (www.diahome.org) is a neutral, global, professional, member-driven associat ion of nearly 18,000 industry, academia, and regulatory professionals involved i n the discovery, development, and life cycle management of pharmaceuticals, medi cal devices, and related products. Through our international educational offerin gs and myriad networking opportunities, DIA provides a global forum for knowledg e exchange that fosters the innovation of products,technologies, and services t o improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, C hina. Contact: Katie Hendrick Health Decisions 2510 Meridian Parkway Durham, NC 27713 US +1.919.967.1111 x116 Khendrick@HealthDec.com http://www.HealthDec.com